FDA review of MS drug extended, EMD Serono says

ROCKLAND, Mass. — The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.

EMD Serono — the U.S. subsidiary of German drug maker Merck KGaA, which uses the name to avoid confusion with U.S.-based Merck — said the FDA had extended the review time for cladribine tablets to Feb. 28. The drug is a disease-modifying drug for relapsing MS.

The FDA gave the drug an expedited review period in July, reducing the standard 10-month review period to six months. EMD said the FDA extended the review period to give it more time for a full review of additional information included in the regulatory application.

DEERFIELD, Ill. — Walgreens’ chief medical officer will discuss the evidence-based medicine design and impact of a diabetes management program delivered by pharmacists at both workplace and community pharmacies during an upcoming conference, the drug store chain said.

Cheryl Pegus will speak during the fifth annual World Research Group’s Diabetes Prevention and Management Forum for Health Plans and Employers in Las Vegas on Dec. 9. Pegus, who joined Walgreens as chief medical officer in May, will present in a session called “Community: The Impact of Pharmacist-Led Interventions,” which will help the audience learn how pharmacists provide cost-effective chronic care management in partnership with other healthcare professionals and positively impact healthcare costs, Walgreens said. Features include:

Driving engagement through convenient face-to-face access to a trusted clinician;

Delivering interventions that drive participation and behavior change; and

WHAT IT MEANS AND WHY IT’S IMPORTANT — Most of the newly elected and re-elected Republican members of Congress, Tea Party candidates in particular, vowed to whittle down or repeal healthcare reform once in office, but the healthcare companies that stand to benefit hope to change their minds, as some of their lobbying activities last quarter have shown.

(THE NEWS: Report: PhRMA’s lobbying efforts total more than $5 million in Q3. For the full story, click here)

The Pharmaceutical Research and Manufacturers of America spent $5.2 million lobbying Congress during third quarter 2010 –– which took place during those critical last few months before the midterm elections –– in part on issues related to healthcare reform. That’s less than the $6.8 million PhRMA spent on lobbying in third quarter 2009, but still enough to send the message that it has a big stake in reform. After all, the Patient Protection and Affordable Care Act, which Barack Obama signed into law in March, will provide health care to 32 million Americans who previously lacked it. That means a lot of new customers for drug makers, retail pharmacies and other healthcare companies and providers.

In addition to PhRMA’s $5.2 million, Walgreens spent $340,000 on lobbying during the quarter, according to published reports, some of which it devoted to lobbying on healthcare reform. Rite Aid spent $50,000 on lobbying during the quarter — compared with $10,000 during the first quarter and $20,000 during the second. Dwarfing both was CVS Caremark, which spent $2.6 million.

Pharmacy retailers also have a quite a bit at stake. In addition to dispensing a lot of the drugs in the first place, many of them provide preventive care services through retail clinics, often at competitive prices. The combination of the healthcare-reform bill’s emphasis on preventive care and the tens of millions of new people it will add to the system could bring in lots of new customers for retail pharmacies as well.

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